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Sugar-coated preparation and production method for the same

a technology of sugar coating and production method, which is applied in the field of sugar coating preparation, can solve the problems of high calorie content, complex production procedure, and high calorie content of sugar coating table, and achieves the effects of high moisture resistance, easy production, and high ability to mask unpleasant odors

Inactive Publication Date: 2014-09-30
WAKUNAGA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a production method for a sugar-coated preparation that has several benefits such as being easy to produce, effective at masking unpleasant odors, and resistant to moisture.

Problems solved by technology

Conversely, the sugar-coated tables have the disadvantage of having a complex production procedure since they are coated by undergoing repeated application of liquid, spreading and drying using a large amount of a sugar coating liquid containing mainly sugar.
In addition, they also have disadvantages with respect to susceptibility to cracking and chipping, having a high calorie content and imparting a high moisture content to the resulting preparation.
Conversely, film-coated tablets have disadvantages with respect to low moisture resistance and little ability to mask unpleasant odors.
Although the coating layer of thin layer sugar-coated tablets is thinner than that of sugar-coated tablets, since these tablets are produced by coating with numerous layers in this manner, the complexity of the production procedure has been considered to be a problem.
On the other hand, although erythritol is preferable for use as the base of the sugar coating layer due to its strong sweet taste and low calorie level, it is difficult to form a sugar coating layer and it is easily crystallized.

Method used

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  • Sugar-coated preparation and production method for the same

Examples

Experimental program
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Effect test

example 1

[0052]120 g of L-cysteine (Taenaka Kogyo Co., Ltd.), 300 g of crystalline cellulose (Ceolus PH-101, Asahi Kasei Chemicals Corp.), 132 g of potato starch (Nippon Starch Chemical Co., Ltd.) were subjected to a fluidized bed granulation method to produce granules using a fluidized bed granulator (MP-01, Powrex Corp.) by spraying 180 g of an aqueous solution of 10% hydroxypropyl cellulose (HPC-SL, Nippon Soda Co., Ltd.). Subsequently, the obtained granules were sized using a sieve (30 mesh) to obtain a sized powder. 2.82 g of silicon dioxide (Maikon F, Tomita Pharmaceutical Co., Ltd.) and 2.82 g of magnesium stearate (Taihei Chemical Industrial Co., Ltd.) were mixed with 536 g of the resulting sized powder in a plastic bag, and the resulting mixed powder was tableted with a rotary tableting machine (Hata Iron Works Co., Ltd.) to a weight of 120 mg, diameter of 7 mm and thickness of 3.8 mm per tablet to obtain uncoated tablets. The composition of the uncoated tablets (amounts in 8 uncoat...

example 2

[0056]312.5 g of L-cysteine (Taenaka Kogyo Co., Ltd.), 781.25 g of crystalline cellulose (Ceolus PH-101, Asahi Kasei Chemicals Corp.), 343.75 g of potato starch (Nippon Starch Chemical Co., Ltd.) were subjected to a fluidized bed granulation method to produce granules using a fluidized bed granulator (FLO-25, Freund Corp.) by spraying 468.8 g of an aqueous solution of 10% hydroxypropyl cellulose (HPC-SL, Nippon Soda Co., Ltd.). (The uncoated tablet composition was the same as in Table 1 of Example 1.) Subsequently, the granules were sized using a sieve (30 mesh) to obtain a sized powder. 6.79 g of silicon dioxide (Maikon F, Tomita Pharmaceutical Co., Ltd.) and 6.79 g of magnesium stearate (Taihei Chemical Industrial Co., Ltd.) were mixed with 1291 g of the resulting sized powder in a plastic bag, and the resulting mixed powder was tableted with a rotary tableting machine (Hata Iron Works Co., Ltd.) to a weight of 120 mg, diameter of 7 mm and thickness of 3.8 mm per tablet to obtain ...

example 3

[0058]Thin layer sugar-coated tablets were obtained in the same manner as Example 2 with the exception of using a sugar coating liquid obtained by dissolving 240 g of D-mannitol (Mannit P, Towa Chemical Industry Co., Ltd.) and 64 g of partially saponified polyvinyl alcohol (Gohsenol EG-05, Nippon Synthetic Chemical Industry Co., Ltd.) in 1216 g of purified water (ratio between D-mannitol and partially saponified polyvinyl alcohol=15:4).

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Abstract

A method is provided for producing a sugar-coated preparation including a solid composition containing a pharmacologically active ingredient and a sugar coating layer. The method comprises a step of forming the sugar coating layer with a sugar coating composition containing one or more sugar-alcohols selected from the group consisting of mannitol and erythritol and a polyvinyl alcohol-based resin. The sugar-coated preparation includes a solid composition containing a pharmacologically active ingredient and a sugar coating layer, wherein the sugar coating layer is made of a sugar coating composition containing one or more sugar-alcohols selected from the group consisting of mannitol and erythritol and a polyvinyl alcohol-based resin.

Description

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS[0001]This application claims the benefit of Japanese Patent Application No. 2011-125729, filed Jun. 3, 2011, which is incorporated by reference herein.FIELD OF THE INVENTION[0002]The present invention relates to a sugar-coated preparation including a sugar-coating layer which is formed by a specific sugar coating composition, and a production method for the sugar-coated preparation. More particularly, the present invention relates to a sugar-coated preparation, having a superior ability to mask unpleasant odor, superior moisture resistance and is provided with a thin sugar layer made by a simple production process, and to a production method for the sugar-coated preparation.BACKGROUND ART OF THE INVENTION[0003]Tablets refer to a product form obtained by compressing a powder or granules and the like into a fixed shape. Since the tablets can be easily transported and enable a fixed dose to be taken easily, the tablets are the most commonl...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): A61K9/36A61K47/32A61K9/14A61K9/28
CPCA61K9/2826A61K9/284A61K9/2893
Inventor SAKATA, YUKOHHIGUCHI, MASAHARU
Owner WAKUNAGA PHARMA CO LTD
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